Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Tale Of Two Pathways: Follow-On Biologics Move Forth In EU, Stall In U.S.

Executive Summary

The European Medicines Agency's endorsement of Sandoz' human growth hormone Omnitrope could put further pressure on U.S. regulators to develop an approval pathway for follow-on biologics

You may also be interested in...



Canada Biosimilars Proposal Requires Extra Studies To Show Substitutability

Substitution of a biosimilar for its reference brand product would not be automatic under the framework proposed by Health Canada for approving what it calls "subsequent entry biologics.

Canada Biosimilars Proposal Requires Extra Studies To Show Substitutability

Substitution of a biosimilar for its reference brand product would not be automatic under the framework proposed by Health Canada for approving what it calls "subsequent entry biologics.

EU Biosimilar Guidance Offers Window To Bypass Comparative Trials

Manufacturers seeking regulatory approval of a follow-on biologic in the EU may be able to forgo clinical comparability trials under certain conditions, according to final guidelines on similar biologics issued by the European Medicines Agency March 8

Related Content

UsernamePublicRestriction

Register

OM013658

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel